Michigan SPARC Trial

Alcohol Use Disorder (AUD) Clinical Trial

— MI-SPARC  

Official title:

The Michigan Sustained Patient-centered Alcohol-Related Care (MI-SPARC) Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04861792
• Other study ID #: R18HS027076
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: March 13, 2023

Study information

• Verified date: March 2023
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Unhealthy alcohol use is a major contributor to morbidity and mortality in the US. Although effective prevention for unhealthy alcohol use and medication treatment for alcohol use disorders (AUDs) can be provided in primary care (PC), they have historically not been included in routine services. As a result, most patients do not receive evidence-based prevention or treatment for unhealthy alcohol use. Several efforts have successfully implemented alcohol-related preventive care-referred to as screening and brief intervention (SBI), but efforts to increase treatment of AUDs with medications have been less successful. Moreover, implementation efforts have usually neglected smaller PC practices, in which most PC is provided.

The Michigan SPARC trial is a partnership between Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle, bringing extensive expertise implementing evidence-based alcohol-related care, and Altarum Institute in Ann Arbor, Michigan, bringing demonstrated success engaging over 500 small to medium Michigan-based PC practices in effective quality improvement (QI) efforts. The project builds on Altarum's innovative approach to implementing new or improved clinical care using practice facilitators to provide continuing medical education and maintenance of certification (CME/MOC) programs to PC providers, along with ongoing support for QI using evidence-based implementation strategies. The KPWHRI team recently finished the highly successful AHRQ-funded Sustained Patient-centered Alcohol-Related Care (SPARC) trial using similar implementation strategies in KP Washington, including use of electronic health records and performance monitoring and feedback, and also developed a patient decision aid to support shared decision-making between patients with high-risk drinking and/or AUDs and their PC providers.

The Michigan SPARC trial combines Altarum's expertise in QI in small-medium PC practices in Michigan with KPWHRI's expertise implementing evidence-based prevention and treatment of unhealthy alcohol use-specifically alcohol SBI and medication treatment for AUDs.

Specific Aims of the Michigan SPARC trial had to be markedly modified due to the trial beginning in March 2020 at the same time as the COVID pandemic. A trial was not possible. The revised aims were to describe alcohol screening, brief intervention, AUD diagnosis and initiation of medication treatment for AUD, before and after the Michigan SPARC model was implemented, in small to medium PC practices in Michigan.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9590
• Est. completion date: March 13, 2023
• Est. primary completion date: March 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults age 18 years and older

• Seen in primary care at a study practice during the practice's study period

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Alcohol
• Alcohol Drinking
• Alcohol Use Disorder (AUD)
• Alcoholism
• Drinking

Intervention

Behavioral:
• Michigan SPARC Quality Improvement Intervention
Practice facilitation, electronic health record (EHR) support, performance monitoring and feedback combined with alcohol-related continuing medical education (CME) and maintenance of certification (MOC) and tools to support alcohol related care including a decision aid for shared decision making about alcohol use disorder (AUD).

Locations

Country	Name	City	State
United States	Altarum Institute	Ann Arbor	Michigan

Sponsors (4)

Lead Sponsor	Collaborator
Kaiser Permanente	Agency for Healthcare Research and Quality (AHRQ) - Funder, Altarum Institute, NORC at the University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention - Screening and brief intervention	The proportion of PC patients who screen positive for unhealthy alcohol use and have BI documented in their EHR.	For Aim 1 the period up to 6 months before the launch date will be compared to the 6 month period after the launch date.
Primary	Treatment - Prescription of AUD medications	The proportion of PC patients who are diagnosed with AUD at a visit who also receive a prescription for medications to treat AUD and are seen for follow-up within 14 days.	For Aim 1 the period up to 6 months before the launch date will be compared to the 6 month period after the launch date.